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Investing.com -- BeOne Medicines AG (NASDAQ:ONC) stock gained 2.5% in pre-market trading after the company announced a positive recommendation from the European Medicines Agency for its cancer drug TEVIMBRA in early-stage lung cancer.
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of TEVIMBRA (tislelizumab) in combination with platinum-containing chemotherapy as a treatment for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. The recommendation is based on results from the Phase 3 RATIONALE-315 study.
The clinical trial showed significant benefits for patients receiving the BeOne treatment. The TEVIMBRA-based regimen achieved a major pathologic response rate of 56.2% compared to 15.0% in the placebo group. Additionally, 40.7% of patients on the TEVIMBRA regimen achieved pathological complete response, compared to just 5.7% in the control group.
The study also demonstrated statistically significant improvement in event-free survival with a hazard ratio of 0.56 and a trend toward better overall survival with a hazard ratio of 0.62.
"TEVIMBRA is already approved in the EU across multiple settings in NSCLC, the most common form of lung cancer, and this positive CHMP opinion expands its potential to help patients earlier in their treatment journey," said Mark Lanasa, Chief Medical (TASE:BLWV) Officer at BeOne.
The safety profile remained consistent with previous studies, with 72.1% of patients in the TEVIMBRA arm experiencing grade 3 or higher treatment-related adverse events compared to 66.4% in the placebo arm.
TEVIMBRA is currently approved in the European Union for multiple cancer indications, including various forms of lung cancer, gastric cancer, esophageal cancer, and nasopharyngeal carcinoma.
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